New Serious Risks in Prostate and Hair-Loss Drugs (Propecia/Proscar)

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The side effects of the most common male-pattern baldness pill – depression, insomnia, erectile dysfunction – may be worse than we thought. And potentially permanent.

Go see your doctor about a receding hairline and there’s a good chance you’ll walk away with a prescription for finasteride – better known by its brand name, Propecia. The FDA-approved pill, which came out in 1997, thickens hair in 65 percent of those who take it. More than 26 new generic versions, priced at less than a dollar a pill (versus $3 for Propecia), have made the drug even more attractive. While the packaging warns of a 1 to 2 percent chance of temporary sexual side effects, millions of men consider it a risk worth taking.

But emerging research and a slew of lawsuits suggest that finasteride may be even more dangerous than previously believed, with side effects – inability to orgasm, painful erections, chronic depression, insomnia, brain fog, and suicidal thoughts – that can last long after patients stop taking the pill.

“My yardstick for treating any patient is what would I do if this were my own son?” says Dr. Nelson Novick, a clinical professor of dermatology at Mount Sinai School of Medicine in New York. “Ten years ago I would have answered differently, but now I would not feel comfortable recommending Propecia to a young, sexually active man.”

Men are embarrassed to discuss sexual side effects with their doctor.

Most dermatologists still prescribe finasteride, explaining that they rarely hear of persistent symptoms from patients. There could be a reason for that, researchers say. Men may have no idea that cognitive side effects would have anything to do with taking a hair-loss pill, particularly if those problems continue after they stop taking the drug. And many would be embarrassed to bring up sexual problems to a dermatologist or researcher, particularly a female. “Sexual impairment induced by antidepressant drugs was underestimated for decades for just this reason,” wrote Thomas Moore, a researcher with the Institute for Safe Medication Practices, in an editorial in the June issue of JAMA Dermatology. More said side-effect estimates for those drugs have since jumped from between 1 and 3 percent to between 30 and 60 percent.

Since 2011, 1,245 lawsuits have been filed against Propecia’s manufacturer, Merck, alleging that the company failed to warn users of a constellation of sexual and cognitive side effects – which patients and physicians call Post-Finasteride Syndrome (PFS) because, they say, symptoms often persist after discontinuing the drug. This spring, the National Institute of Health added PFS to its rare-diseases database. And in March, a California woman filed the first wrongful death suit against Merck. Her husband, a 40-year old IT executive and father of two with no history of mental illness, killed himself in March 2013. His family blames finasteride.

In a statement, Merck said the company “stands behind the demonstrated safety and efficacy profile of Propecia.” In recent years, it also added depression and persistent sexual problems to its list of possible side effects, deep in the fine print. It intends to defend itself vigorously when the first cases go to court, likely in 2016. The company will undoubtedly argue that millions use Propecia without harm – sales hit $264 million in 2014 – and that serious problems are rare.

Not rare enough, says Steven Rossello, a 32-year old who filed the first suit against Merck, in 2011. “There’s a lot of talk about sexual side effects, but the worst effects are the mental ones,” Rossello says. Despite stopping the drug in 2010, he says he suffered a finasteride-induced long-term depression that cost him his fiancée and job as an agent with the Department of Homeland Security.

It’s leading to depression and suicide.

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Recent research suggests that finasteride can impact levels of neuro-protective, mood-regulating steroids in the brain, explains Dr. Michael Irwig, an associate professor of medicine at George Washington University whose research has linked its use to depression and suicidal tendencies. According to a review published in Pharmacotherapy in July, the FDA has received more than three-dozen reports of suicidal tendencies among Propecia users. Most resulted in hospitalization, death or disability.

“Patients and physicians have been falsely reassured,” says Steven Belknap, an assistant professor of dermatology at Northwestern University. In a meta-analysis published in JAMA Dermatology in April, he reviewed the 34 clinical trials performed on finasteride and found that “none adequately assessed safety,” and all underreported potential adverse effects. “It is stunning,” says Belknap. “Here we are 18 years after the initial approval, and if someone were to ask me if this drug is safe, I would have to say ‘I don’t know.’” Merck, in its statement, said it “conducted well-designed clinical trials.”

Why do so many doctors still prescribe the drug? The research on its cognitive side effects is relatively new, and the number of patients reporting problems low, dermatologists say. “I don’t hesitate to prescribe it to appropriate patients, but I do spend more time now counseling them about the risks,” says Boulder, Colorado, dermatologist Jeanie Leddon.

There’s a scary and frightening history behind the drug.

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Knowing the drug’s origins might prompt some to shy away from it. Finasteride has its roots in the 1970s, when scientists discovered a rare group of men in the Dominican Republic who were born with ambiguous genitalia and often mistakenly raised as girls. These men possessed other unique traits: They never lost their hair or had prostate problems. This was because they failed to produce an enzyme that converts testosterone to dihydrotestosterone, or DHT. DHT is critical for fetal development of male genitals, but in adults it impairs hair growth. Enter Merck, which unveiled a compound – finasteride – that slashes DHT levels 70 percent. As Belknap puts it, the drug works by mimicking the sex-steroid profile of pseudohermaphrodites. Some former male users equate this to “chemical castration.” To this day, health officials warn women not to even touch finasteride pills, because in doing so could cause genital malformations in an unborn boy.

And it’s also being widely used for prostate problems.

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In 1992, drug companies rolled out a finasteride tablet to treat an enlarged prostate (Proscar). It’s still prescribed by urologists who contend that, in this case, avoiding serious health problems outweigh the risk. Propecia, however, is a different story. “This is cosmetic,” stresses Belknap. “This is not a lifesaving drug.” And one that may come with a steep price.

Keep the hair you have – naturally.

Three non-pharmaceutical strategies to help slow thinning hair.

Try this herb:

Dermatologists recommend saw palmetto – a dietary supplement – as a milder, plant based alternative to the hair-loss drug Propecia; it’s the only herbal supplement with research to back up its effectiveness to slow hair loss. Dr. Shani Francis, director of the Hair Disorders Center of Excellence at the University of Chicago, recommends 160 mg of dried extract twice per day.

Massage your scalp:

“A lot of guys with thinning hair try not to touch it,” says New York City grooming expert Vaughn Acord, “But the more you touch the scalp, the more blood flow you get to the skin.” This can help keep follicles healthy.

Use the right shampoo:

Look for antidandruff and hair-thickening shampoos. The former have ingredients that combat yeast, which can cause inflammation and hair shedding. The latter contain proteins like keratin that make hair look fuller.

High-Tech Hair Growth

New treatments to battle male-pattern baldness – minus the side effects

Platelet-Rich Plasma Therapy (PRP)

What it is: “PRP uses your own cells to regenerate the cells in the scalp responsible for hair growth,” says Joseph Greco, the first practitioner to use PRP as a hair-loss treatment. PRP has been shown to spur healing in other areas, such as the heart or an injured knee.

How it works: Doctors draw blood and spin it in a centrifuge to isolate protein-rich plasma, packed with molecules believed to slow cell death, boost blood-vessel formation, and quell inflammation inside follicles. They inject the liquid across 40 spots on the scalp. Studies have shown PRP can widen the hair shaft and make hair thicker. In clinical trials, it worked in 55 percent of users.

Cost: About $1,500 per treatment, required every six months.

Laser Therapy

What it is: Since 2007, when the FDA cleared the first red-light laser comb, many at-home laser emitting brushes, helmets, and caps have emerged. Manufacturers recommend a few brushes or 15 minutes under the cap every other day.

How it works: The low-intensity red light can grow hair because “follicles in the resting stage get stimulated into the active hair-growing stage,” says phototherapy researcher Michael Hamblin, an associate professor of dermatology at Harvard Medical School. Research on the therapy is slight, but a promising 2014 study found that those who used a laser comb three times per week noticed a clear improvement in how their hair looked.

Cost: From $300 for a comb to $700 for a cap.

Latisse (Bimatoprost)

What it is: Bimatoprost was originally used to reduce pressure inside the eyes of glaucoma patients. When their eyelashes grew so long they brushed against their glasses, the drug company Allergan took note and created the eyelash enhancing cream Latisse. While it’s not officially approved for male-pattern baldness, some physicians and online hair-loss forums suggest using Latisse off-label.

How it works: The cream may curb production of prostaglandins, which inflame hair follicles and slow hair growth.

Cost: $180 for a 5 ml tube, which could last about a week.

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*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease. ProstateSupplements.com is affiliated with Prost-P10x.

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